An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
NHS Trust
An Organisation-wide Document for the
Reporting and Management of Incidents
Including Serious Incidents
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Name of executive lead:
Date issued:
Review date:
Target audience:
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
Contents
1
Introduction ............................................................................................................. 5
2
Purpose .................................................................................................................... 5
3
Explanation of Terms ............................................................................................... 5
4
Duties ....................................................................................................................... 8
4.1
4.2
5
Duties within the Organisation ............................................................................................... 8
Committees and Groups with Overarching Responsibilities .................................................. 9
Response, Communication and Notification ......................................................... 10
5.1
5.2
5.3
5.4
5.5
6
Immediate Response by the Organisation ............................................................................ 10
Reporting the Incident .......................................................................................................... 10
Patient/Relative/Visitor/Contractor Communication and Support ...................................... 11
Internal Communication ....................................................................................................... 11
External Stakeholder Notification ......................................................................................... 11
Communication with Staff ..................................................................................... 12
6.1
6.2
7
Communication Following an Incident ................................................................................. 12
Process by which to Raise Concerns ..................................................................................... 12
Media Involvement ................................................................................................ 12
7.1
7.2
7.3
Media Unaware of Serious Incident ..................................................................................... 13
Media Unaware but Proactive Media Handling Necessary .................................................. 14
Media Aware of Serious Incident .......................................................................................... 14
8
Hotline Arrangements ........................................................................................... 14
9
Incident Investigation ............................................................................................ 15
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
Incident Grading and Appropriate Levels of Investigations .................................................. 15
Responsibility for Investigation............................................................................................. 15
Responsibility for Causal Factor Analysis .............................................................................. 16
Responsibility for Causal Factor Analysis Post Investigation ................................................ 16
Involving Patients and their Families in Investigations into Serious Incidents ..................... 16
Involvement of Relevant Stakeholders ................................................................................. 16
Root Cause Analysis (RCA) and Investigation Report............................................................ 17
Recommendations and Action Planning ............................................................................... 17
Monitoring of Action Plans ................................................................................................... 17
Process of Ensuring Continual Risk Reduction Following the Implementation of Action Plans
17
Sharing of Lessons Learnt ..................................................................................................... 17
10
Equality Impact Assessment ............................................................................... 19
11
Monitoring Compliance with the Document ..................................................... 19
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11.1
11.2
12
12.1
12.2
13
Process for Monitoring Compliance ..................................................................................... 19
Standards/Key Performance Indicators ................................................................................ 19
References .......................................................................................................... 19
Legislation ............................................................................................................................. 19
Guidance from Other Organisations ..................................................................................... 20
Associated Documentation ................................................................................ 21
Appendix A - Incident Reporting Timescales ................................................................ 22
Appendix B - Incident Reporting Form ......................................................................... 22
Appendix C - Guide to Incident Form Completion ....................................................... 22
Appendix D - Risk Grading Tool - 5x5 ........................................................................... 22
Appendix F - Grading and Timescales for Investigation ............................................... 24
Appendix G - List External Stakeholders....................................................................... 25
Appendix H - Action Learning Points ............................................................................ 28
Appendix I - Guidance on How to Write a Statement .................................................. 29
Appendix K - Template Document for the Reporting and Management of Incidents
Including Serious Incidents ........................................................................................... 33
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
Review and Amendment Log
Version no.
Type of change
Date
Description of change
V.4
Annual review
Mar 2011
Update to section 10 ‘References’
V.4
Amendment
Mar 2011
Addition of amendment log
Addition of example of definition
Addition of examples of associated documents
V.5
Amendment
Mar 2012
Change to format including automated
contents page
Please Note the Intention of this Document
This document has been developed with the aim of providing a model document template.
However, any documentation subsequently produced must follow its own rules and include details
of all the requirements set out in sections 1-11, where relevant. The organisation may use this
template and adapt it to reflect procedures within the organisation or alternatively use a document
already in existence. Whichever approach is used the organisation must ensure it is compliant with
the minimum requirements of the relevant National Health Service Litigation Authority (NHSLA) Risk
Management Standards.
a
To assist the organisation, areas have been identified in the margins where the section
within the template document relates to the minimum requirements for the criterion in the
relevant NHSLA Risk Management Standards.
It is important that the document should follow any pre-existing guidance within the organisation in
relation to style and format of documentation. Please note that a template document entitled An
Organisation-wide Document for the Development and Management of Procedural Documents can
be found on the NHSLA website which may provide the organisation with additional guidance.
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1
Introduction
Serious incidents in healthcare are relatively uncommon but when they do occur the NHS
has a responsibility to ensure that there are systemic measures in place for safeguarding
people, property, NHS resources and reputation. This includes the responsibility to learn
from these incidents in order to minimise the risk of them happening again. This section
should introduce the importance of establishing a safety culture within an organisation; a
reporting culture, which appreciates the significance of effective incident management.
Incident reporting is a fundamental tool of risk management, the aim of which is to collect
information about adverse incidents, including near misses, ill health and hazards, which will
help to facilitate wider organisational learning. If incidents are not properly managed, they
may result in a loss of public confidence in the organisation and a loss of assets.
Incident reporting is more likely to take place in an organisation where there is a well
developed safety culture and where there is strong leadership. This section should explain
that the chief executive and directors (including non-executives) support open and
transparent systems of patient and staff safety , and that it is unacceptable to prioritise
other objectives at the expense of safety.
The reporting and management of incidents will lead into the processes described in the
organisation’s document for the investigation of incidents, complaints and claims, and the
document for analysis and improvement following incidents, complaints and claims.
(Template documents for these stages of the process are available on the NHSLA website).
2
Purpose
This section should describe how the organisation intends to ensure that all incidents,
whether they have caused actual harm, or were a near miss, are reported by staff in a timely
manner. This section should describe how there is an intention to appropriately manage
and investigate incidents, based on their severity, and to ultimately learn and make changes
as a result of incidents, complaints and claims in order to improve safety for patients, staff,
visitors and contractors.
This section should include a statement regarding the non-punitive approach the
organisation takes towards incident reporting. Organisations should consider the NPSA
publications Seven Steps to Patient Safety (2004) and the National Framework for Reporting
and Learning from Serious Incidents Requiring Investigation (2010).
3
Explanation of Terms
This section should list and describe the meaning of the terms used within the context of the
document. The following list is a guide only and not exhaustive:

NHS funded services and care
Healthcare that is partially or fully funded by the NHS, regardless of the location.

Incident
An event or circumstance which could have resulted, or did result, in unnecessary damage,
loss or harm to patients, staff, visitors or members of the public.

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Serious incident requiring investigation
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A serious incident requiring investigation is defined as an incident that occurred in relation
to NHS funded services and care resulting in one of the following:


the unexpected or avoidable death of one or more patients, staff, visitors or
members of the public;

permanent harm to one or more patients, staff, visitors or members of the
public, or where the outcome requires life saving intervention or major
surgical/medical intervention, or will shorten life expectancy (this includes
incidents graded under the NPSA definition of severe harm (Seven Steps,
2004, p100);

a scenario that prevents, or threatens to prevent, a provider organisation’s
ability to continue to deliver health care services, for example, actual or
potential loss or damage to property, reputation or the environment;

allegations of abuse;

security incidents;

adverse media coverage or public concern for the organisation or the wider
NHS; or

one of the core set of Never Events.
Never Events
Never Events are serious, largely preventable patient safety incidents that should not occur
if the available preventative measures have been implemented. These are updated on an
annual basis and currently include (DH 2011):
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
wrong site surgery;

wrong implant/prosthesis;

retained foreign object post-operation;

wrongly prepared high-risk injectable medication;

maladministration of potassium-containing solutions;

wrong route administration of chemotherapy;

wrong route administration of oral/enteral treatment;

intravenous administration of epidural medication;

maladministration of insulin;

overdose of midazolam during conscious sedation;

opioid overdose of an opioid-naïve patient;

inappropriate administration of daily oral methotrexate;

suicide using non-collapsible rails;
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

escape of a transferred prisoner;

falls from unrestricted windows;

entrapment in bedrails;

transfusion of ABO-incompatible blood components;

transplantation of ABO or HLA-incompatible organs;

misplaced naso- or oro-gastric tubes;

wrong gas administered;

failure to monitor and respond to oxygen saturation;

air embolism;

misidentification of patients;

severe scalding of patients; and

maternal death due to post partum haemorrhage after elective caesarean
section.
Security incident
From April 2010 NHS Protect introduced a Security Incident Reporting System. This was
developed to provide a clearer picture of security incidents across the health service in
England, locally and nationally. This is a key step towards building a safer NHS where people
and property are better protected. SIRS coincides with the extended requirements for
reporting to NHS Protect. The following security incidents must be reported using SIRS:


any security incident involving physical assault of NHS staff;

non-physical assault of NHS staff (including verbal abuse, attempted assaults
and harassment);

theft of or criminal damage (including burglary, arson, and vandalism) to
NHS property or equipment (including equipment issued to staff); and

theft of or criminal damage to staff or patient personal property arising from
these types of security incident.
Unexpected death
Where natural causes are not suspected; local organisations should investigate these to
determine if the incident contributed to the unexpected death.

Permanent harm
Harm directly related to the incident and not to the natural course of the patient’s illness or
underlying conditions; defined as permanent lessening of bodily functions, including
sensory, motor, physiological or intellectual.
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
Prolonged pain and/or prolonged psychological harm
Pain or harm that a patient has experienced, or is likely to experience, for a continuous
period of 28 days.

Severe harm
Any patient safety incident that appears to have resulted in permanent harm to one or more
persons receiving NHS funded care.

Major surgery
A surgical operation within or upon the contents of the abdominal or pelvic, cranial or
thoracic cavities, or a procedure which, given the locality, condition of patient, level of
difficulty, or length of time to perform, constitutes a hazard to life or function of an organ, or
tissue (if an extensive orthopaedic procedure is involved, the surgery is considered ‘major’).
The NPSA has an anaesthetic e-form for reporting anaesthesia events that organisations can
report on. The e-form can be found at: Link

Abuse
A violation of an individual’s human or civil rights by any other person or persons. Abuse
may consist of single or repeated acts. It may be physical, verbal or psychological; it may be
an act of neglect or an omission to act, or it may occur when a vulnerable person is
persuaded to enter into a financial or sexual transaction to which he or she has not
consented, or cannot consent. Abuse can occur in any relationship and may result in
significant harm, or exploitation, of the person subjected to it. This is defined in No secrets:
Guidance on developing and implementing multi-agency policies and procedures to protect
vulnerable adults from abuse (DH 2000), and Working Together to Safeguard Children: A
guide to inter-agency working states that abuse and neglect are forms of maltreatment of a
child. Somebody may abuse or neglect a child by ‘inflicting harm’ or by failing to act to
prevent harm (DCSF 2006, p37).

Working days
Days that exclude weekends and bank holidays (Run from 23:59 on the day the incident is
raised to 23:59 on the day the incident is reported).
a
4
Duties
Give a brief overview of the roles, responsibilities and accountabilities for the
implementation of the organisation’s process. This section should be a brief overview only
and the details of the process for managing this should be incorporated within later sections
of the document. The following list is a guide only and is not exhaustive:
4.1
Duties within the Organisation
Some example responsibilities have been identified below; however, these should
be considered within the context of the individual organisational structure.
Chief Executive
This section should state that the chief executive is ultimately accountable for the
implementation of this organisation-wide process, and a reiteration of their nonpunitive stance should be included here.
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Senior Manager
Roles and responsibilities of the senior management and how their involvement
with the incident should be documented.
Line Manager
The role to be taken by the line manager, including any immediate actions which
need to be taken post incident, should be described including any documentation
which needs to be completed. The organisation should set out who will inform the
line manager and who else within the organisation needs to be contacted and when.
There is a list of external stakeholders at Appendix G.
Risk Manager/Equivalent
Roles and responsibilities of the risk manager and how their involvement with the
incident should be documented.
All Staff
Document the responsibly of all staff to report incidents in a timely manner. A cross
reference may be required to the organisation’s document for supporting staff
following a traumatic incident.
4.2
Committees and Groups with Overarching Responsibilities
Trust Board
For effective implementation of the Organisation-wide Document for the Reporting
and Management of Serious Incidents there must be active support from the most
senior members of the organisation. Organisations should detail how the chief
executive and the nominated directors are to gain assurance that this document is
being implemented within the organisation, and how they intend to be made aware
of the serious incidents, and the more high frequency, low risk incidents. There
must be effective cooperation at all levels of the organisation in order for this
process to be successful.
Committee with Overarching Responsibility for Risk Management
Roles and responsibilities of the committee(s) with overarching responsibility for risk
management should be documented. This should include how all incidents, nonclinical and clinical, are integrated and reported to the relevant committees; the
committee’s role in ensuring actions are taken as a result of trend analysis; and the
cascading of information throughout the organisation.
The reporting and management of incidents will lead into the processes described in
the organisation’s document for analysis and improvement following incidents,
complaints and claims. (A template document is available on the NHSLA website).
Responsibility for monitoring the completion of the action plans and the subsequent
effectiveness of any risk reduction measures introduced should be included within
this section.
Inclusion/description of the terms of reference for this committee including
accountability, responsibility, authority, membership (including co-opted members
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and deputies), the meeting schedule and quorum, etc. It is considered good
practiceto date and sign the terms of reference and apply a review date.
Other Committees/Groups with Responsibilities for Incident Management
Many other groups/committees have a role in the management of incidents. This
section will need to include the role of other corporate/organisation-wide
committees, e.g. the training and education group, or health and safety committee,
or more locally based groups, which are responsible for ensuring the lessons learnt
organisationally are introduced into the service areas/departments.
5
Response, Communication and Notification
5.1
Immediate Response by the Organisation
In all instances, the first priority for the provider organisation is to ensure the needs
of individuals affected by the incident are attended to, including any urgent clinical
care which may reduce the harmful impact.
A safe environment should be re-established, all equipment or medication retained
and isolated, and all relevant documentation copied and secured to preserve
evidence to facilitate the investigation and learning. If there is a suggestion that a
criminal offence has been committed, the organisation should contact the police.
The organisation should give early consideration to the provision of information and
support to patients, relatives and carers and staff involved in the incident. This
section should include information regarding any support systems which are
available to patients/relatives/visitors/contractors. The organisation should follow
guidance provided in the ‘being open’ document.
The needs and involvement of staff in the incident should also be considered. The
NPSA’s Incident Decision Tree (NPSA 2008) resource can assist here.
If the incident is a potential adult safeguarding concern, organisations should have
established and robust local processes in place and a safeguarding alert raised. It is
also important to identify where other agencies need to be brought into the
management of a serious incident when required. Cross reference should be made
to the list of external stakeholders at Appendix G.
b
5.2
Reporting the Incident
This section should set out the timescales involved with incident reporting: when the
incident should be reported both to the immediate line manager and then centrally
to the risk management department. This section should illustrate the need to
grade the incident, what immediate actions should be taken and what
documentation needs to be completed. The organisation could add the following to
this document as appendices: the incident report form, a guide to incident form
completion, the risk matrix, and the list of potentially reportable incidents.
Reporting Timescales
All identified serious incidents must be notified to the relevant bodies without delay.
This section should set out who will be responsible for such reporting and how this
will be achieved. There is a list of external stakeholders at Appendix G.
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This section should provide the details about the communication and notification
processes to be followed by the organisation, particularly to the NPSA and to the
Strategic Executive Information System (STEIS) or local serious incident reporting
systems. In addition, some serious incidents require organisations to fulfil reporting
requirements to other bodies as appropriate. Strategic Health Authorities (SHAs)
may disseminate separate requirements for using STEIS or local serious incident
reporting systems to complement this document.
From 1st April 2010, as part of the registration requirements arising from the Health
and Social Care Act 2008, organisations are required to notify the Care Quality
Commission (CQC) about events that indicate or may indicate risks to ongoing
compliance with registration requirements, or that lead or may lead to changes in
the details about the organisation in the CQC's register.
5.3
Patient/Relative/Visitor/Contractor Communication and Support
Communication with patients and/or their relatives, visitors or contractors will
normally need to take place both pre and post investigation. This section should
define who within the organisation is responsible for verbal/written communication;
when communication is to take place; and how this information should be
documented. This section should include information regarding any support
systems which are available to patients/relatives/visitors/contractors.
This
communication needs to follow the principles of ‘being open’ and this information
could be included within this document or there could be a clear cross reference to
the organisation’s ‘being open’ document.
5.4
Internal Communication
This section should describe who within the organisation needs to be informed of an
incident at all levels, who is to inform them and the timescales which must be
adhered to.
c
5.5
External Stakeholder Notification
Reporting Responsibilities
NHS Organisations
NHS organisations, including providers of community services, are accountable to
commissioning bodies through contracting and commissioning arrangements. NHS
organisations are also regulated by the CQC. This section should set out who will be
responsible for such reporting and how this will be achieved.
Foundation Trusts
NHS Foundation Trusts and their board of directors are accountable to
commissioning bodies through contracting and commissioning arrangements, and to
their governors and members. Foundation Trusts are regulated by Monitor for
compliance with their terms of authorisation. Serious incidents in Foundation Trusts
should be reported to the lead commissioning body and must be reported to the
NPSA. Foundation Trusts that breach or risk breaching their terms of authorisation
are also required to report all serious incidents to Monitor. They are required to
have adequate processes and procedures in place to identify, report and take
appropriate action on a timely basis in relation to serious incidents, and to identify
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
key stakeholders and inform these as appropriate. At the time of publication of this
template document all serious patient safety incidents should be reported to the
NPSA and to the STEIS or local serious incident reporting systems. In addition, some
serious incidents require organisations to fulfil reporting requirements to other
bodies as appropriate, as described in the information resource to support the
reporting of serious incidents on the NPSA’s website.
Independent Providers of NHS Care
Non-NHS providers, including independent provider organisations and practitioners,
are accountable to commissioning bodies through contracting and commissioning
arrangements, and through national contracts. This section should set out who will
be responsible for such reporting and how this will be achieved.
6
Communication with Staff
6.1
Communication Following an Incident
Communication with staff may need to be both pre and post investigation. Staff
personally involved in the incident itself and other staff within the organisation may
need to be involved in discussions. This section should define who is responsible for
this communication; when communication is to take place; and how this
communication needs to be documented. The section should include information
regarding any support systems which are available to staff. Cross reference could be
made available to the organisation’s document for supporting staff.
d
6.2
Process by which to Raise Concerns
There is a need for staff to be aware of how to raise their concerns regarding near
miss incidents; this information could be included within this document, or there
could be a clear cross reference to organisational documents such as the whistle
blowing or raising concerns procedures.
7
Media Involvement
Communications are a vital element of supporting and delivering effective management of
serious incidents. The organisation is responsible for ensuring that robust communications
and media management arrangements are in place for both internal and external
communication.
In many cases serious incidents can lead to a high level of media attention and not only in
the immediate aftermath. The management, investigation and learning from incidents can
be triggers for media coverage for an extended period after the incident itself. The
organisation should describe the media handling strategies in place which include the
appropriate action to be taken in relation to serious incidents, including protocols with other
local organisations and agencies on media handling and strategies for ongoing and longer
term management of media coverage.
This section should include the requirement for communication leads to work closely with
the SHA communications professionals to agree appropriate media handling strategies,
working alongside the relevant colleagues responsible for the wider management of the
incident. Responsibility for briefing the Department of Health Ministerial Briefing Unit or
Media Centre rests with the SHA; therefore they need to be accurately briefed in a timely
manner.
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In forensic/criminal cases, the police lead all communications with the media and liaise with
the relevant agencies where they have involvement in the incident.
The organisation should describe how the problem will be understood and how steps being
taken to put it right in order to provide reassurance that the risks of the same thing
happening again have been minimised. This is the key principle that should inform all public
and media contact. Local judgment should be applied in deciding when help lines and
counselling are necessary; how patients are contacted and when to hold press briefings on
and off the record, as well as press conferences. The section should describe how decisions
will be taken between the communications professional at the SHA in consultation with the
serious incident team and the organisation.
Generally there are three communication categories which will determine how a serious
incident may be handled:

the media is unaware of a serious incident;

the media is unaware of a serious incident but should be informed so it can help
with the handling of the incident by notifying the general public and/or section of
the public of, for example, the need to come forward for re-testing following a
screening programme incident; or

the media is aware of an incident first and in this case the SHA/commissioning
body/provider organisation may have only learned of a problem because it has been
publicised by the media or the handling of an ongoing serious incident has ‘leaked’
into the public domain.
7.1
Media Unaware of Serious Incident
It is essential that a holding statement for the media is prepared as soon as possible
so that the organisation is prepared. This will require revision depending upon how
well a subsequent media inquiry is informed.
Some types of incident such as those involving screening programmes can involve
contacting patients for recall or reassurance. Where this is the case all attempts
should be made to contact patients before the media is alerted (where the media is
unaware of the serious incident or where you have to seek the media's assistance),
as long as it does not compromise patient safety in any way. However, contacting
patients hugely increases the chances of the serious incident reaching the public
domain and the media ahead of planned management. Prior to making contact with
patients there should ideally be a reactive media handling strategy in place.
However, any delay in such circumstances should not place patients at any increased
risk of harm. This section should document the process for informing
patients/staff/relatives and other persons (i.e. contractors involved in or affected by
the event) before the media, and who within the organisation will be tasked with
dealing with and coordinating such communications.
Another source of information reaching the public domain is from health care staff.
Such instances may be accidental or deliberate. For example, if staff believe
managers are not taking seriously their concerns about a serious incident or if they
do not seem to be acting on their warnings then there is a high likelihood of the
story ‘leaking’ to the media.
Therefore the organisation should document how health care managers will:
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7.2

keep staff informed;

show they are taking their concerns seriously and acting upon them; and

include staff so they have ownership and understand the need to observe
patient and service confidentiality; the former is readily accepted by staff,
but the latter only if they understand and believe that by going to the press
they will cause more harm than good for patients and the service.
Media Unaware but Proactive Media Handling Necessary
A proactive media approach should be followed where time and wider public health
concerns can only be addressed through this route, for example, after the loss of
personal data records where the only way a large number of patients can be
contacted is by public appeal.
This section should set out how communication leads will ensure they know the
extent of the problem; explain why the media's assistance is needed; how those
affected will be supported; and what will be or has been done to ensure there will
be no repeat of the incident:
7.3

understand the problem;

put it right;

reassure; and

robust and secure feedback channels (help lines if appropriate).
Media Aware of Serious Incident
Those directly involved in the incident, including the investigation team and head of
communications, need time, space and support and it is the role of communication
leads to provide this space whilst keeping journalists informed. This includes
planning for the next stage, posing solutions and recommended handling to help
support investigation and use the team most effectively. Under these circumstances
the need to rapidly establish the facts and fully understand the extent of the
problem and its cause is even more essential.
It is important to keep the public and media informed and share communications
with partner agencies in advance of public information release, whilst balancing the
needs of the affected people, staff and patients. The organisation should describe
how staff will be kept informed so they understand why and how the organisation is
acting, their role and ownership in fixing the problem and the organisation’s
communication plans.
8
Hotline Arrangements
This section should provide a clear explanation of how the organisation will manage an
incident which has affected a large number of individuals who may need either to be
contacted by, or who may need to contact, the organisation. The section could cover:
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
management responsibility;

phone lines;
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9

staffing;

capacity to manage calls over time;

documentation;

record keeping;

IT and postal arrangements; and

e-form.
Incident Investigation
This section should detail the process of investigation to be conducted by the organisation,
and a description of how the organisation intends to monitor the completion of action plans
and the subsequent sharing of lessons learnt. The organisation may refer to a separate
investigation procedure for incidents, complaints and claims. A template document, An
Organisation-wide Document for the Investigation of Incidents, Complaints and Claims is
available.
9.1
Incident Grading and Appropriate Levels of Investigations
This section should describe how different grades of incidents will require different
depths of investigation, and how various levels of management may undertake
them. The section should include the need for re-grading the incident post
investigation. This section should describe (and cross reference to the appropriate
document) the process for getting any significant risks onto the organisation’s risk
register and the process for getting lesser risks onto local risk registers. Appendix E
is a guide to the serious incident grades developed by the NPSA, timescales and
monitoring requirements. Grading should be agreed by the accountable SHA and
provider organisations on an individual case by case basis and with advice from
specialist sources where appropriate. It is recommended that investigations follow
the NPSA guidance and identify both active (e.g. acts and omissions by staff) and
latent (e.g. organisational or environmental issues) failures. If only active failures
are identified the resulting solutions are unlikely to maintain sustainable prevention.
9.2
Responsibility for Investigation
This section should describe who within the organisation will have responsibility for
the investigation of incidents of all severity. Organisations should refer to the
NPSA’s Seven Steps to Patient Safety - Your Guide to Safer Patient Care (2004).
There are likely to be training requirements, which should be stated, or cross
referenced to the organisational training needs analysis. Where the investigation
involves more than one organisation, anything uncovered by local investigations
that may be pertinent, e.g. timelines, care/service delivery problems and causal
factors, should be communicated to the agreed lead organisation to ensure a full
analysis of the incident and root causes to be determined.
Allegations of abuse should always be referred immediately to local multi-agency
safeguarding arrangements for adults and children and a safe guarding alert raised.
Safeguarding investigations are coordinated by those arrangements and should not
begin independently of them.
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9.3
Responsibility for Causal Factor Analysis
This section should include a description of who undertakes this analysis; how often
it should take place; which committees the analysis will be submitted to; and how
this information ultimately informs the board. This analysis should be both
qualitative and quantitative in nature, and discuss any trends that have been
identified, e.g. if there has been a growing trend in communication issues, has this
been due to poor written information, poor verbal information, communication
between professional groups, communication between different sites or
communication with other neighbouring organisations?
9.4
Responsibility for Causal Factor Analysis Post Investigation
The organisation will uncover a number of causal factors during an investigation,
which will undoubtedly lead to the identification of trends. For example:
communication, training, equipment, etc; this analysis could be extremely useful for
the organisation. Included within this section should be the responsibility for this
trend analysis and how often it will be required to take place. It may also be useful
to describe how this information will be collated and disseminated throughout the
organisation.
This information could be included within this document, or there could be a clear
cross reference to the organisational document which describes the process for
ensuring a systematic approach to the analysis of incidents, complaints and claims
on an aggregated basis.
9.5
Involving Patients and their Families in Investigations into Serious Incidents
The level of patient/family involvement clearly depends on the nature of the
incident and the patient or family’s wish to be involved, but provider organisations
should have an organisational Being open document in place, which staff are aware
of and the principles of which are in current use. Unless there are specific
indications to the contrary or the patient/their family requests other arrangements,
these issues should be covered in a series of ongoing open discussions between the
staff providing the patient’s care and the patient and/or their relatives or carers.
Note: Patients and families have the right to request information held by public
authorities (Freedom of Information Act 2000). This includes access to medical
records and any associated documentation (The Re-use of Public Sector Information
Regulations SI 2005/1515). This should be considered when writing incident
investigation reports and actions.
9.6
Involvement of Relevant Stakeholders
This section should describe the possible involvement of external agencies such as
the Health and Safety Executive (HSE), the Medicines and Healthcare products
Regulatory Agency (MHRA), the police or the Environmental Health Agency (EHA)
etc. They may be needed to help investigate certain incidents which may be outside
the expertise of those within the organisation. This section should define whose
responsibility it is to contact these agencies, and when their involvement may be
requested. It may also be necessary, if an incident occurs across a number of
organisational boundaries, to work together in a joint investigation, and this section
could be used to describe how such investigations may be managed. Cross reference
should be made to Appendix G, the list of external stakeholders.
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9.7
Root Cause Analysis (RCA) and Investigation Report
This section should describe how the root cause analysis and investigation report
will be compiled, or provide a cross reference to the organisation’s root cause
analysis document. An investigation executive summary (using the template in
Appendix J) should be published for each serious incident. It should include a précis
of the incident and investigation and be fully anonymised to preserve confidentiality
of the people involved and the ward/team/unit/hospital and provider organisation.
This will enable the executive summary to be widely shared.
The NPSA’s Root Cause Analysis (RCA) investigation report writing templates (2010)
could be used.
9.8
Recommendations and Action Planning
This section should document the need for recommendations to be made post
investigation, and for a detailed action plan to be produced. Action plans should
include persons responsible and the date for completion.
9.9
Monitoring of Action Plans
In this section the organisation should include a description of how action plans
produced as a result of investigations are monitored in order to ensure their
completion. This may be a specific responsibility for a committee or for nominated
individuals.
9.10
Process of Ensuring Continual Risk Reduction Following the Implementation of
Action Plans
This section should describe how the organisation will ensure that those risk
reduction measures taken post investigation are continuing to be effective, and that
risk has not been transferred unwittingly.
9.11
Sharing of Lessons Learnt
The sharing of the lessons learnt post investigation is a critical part of incident
management.
Learning from patient safety incidents is a collaborative,
decentralized and reflective process that draws on experience, knowledge and
evidence from a variety of sources. The learning process is a process of change
evidenced by demonstrable, measurable and sustainable change in knowledge,
skills, behaviour and attitude. Learning can be demonstrated at organisational level
by changes and improvements in process, policy, systems and procedures relating to
patient safety within healthcare organisations. Individual learning can be
demonstrated by changes and improvements in behaviour, beliefs, attitudes and
knowledge of staff at the front line of healthcare delivery.
What Constitutes Learning
Learning following an incident should be linked to safety related policy, practice and
process issues raised by the incident. Examples of learning are given below:

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solutions to address incident root causes which may be relevant to other
teams, services and provider organisations;
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
identification of the components of good practice which reduced the
potential impact of the incident, and how they were developed and
supported;

systems and processes that allowed early detection or intervention which
reduced the potential impact of the incident;

lessons from conducting the investigation which may improve the
management of investigations in future; and

documentation of identification of the risks, the extent to which the risks
have been reduced, identified and how this is measured and monitored.
Learning points should be grouped or themed to help the reader(s) identify those
points applicable to their team, service, speciality, division or wider organisation as
depicted in Appendix H - Action Learning Points.
Summary Points for Dissemination of Learning from a Serious Incident
This section should include a clear description of how this sharing of information is
to take place, and how findings of investigations are disseminated throughout the
organisation. It may also be good practice to include how lessons could be shared
across organisational boundaries. The organisation may include a cross reference to
the organisational document which describes the process for encouraging learning
and promoting improvements in practice, based on individual and aggregated
analysis of incidents, complaints and claims.
Identifying Issues which may be of National Significance
Investigations may identify issues of national significance or where the
dissemination of national learning is appropriate. Organisations such as the NPSA,
MHRA, HPA, HSE, etc. have review, response and alert mechanisms for urgent
incidents. As already stated, relevant incidents should be notified to these bodies as
part of the serious incident reporting process and provider organisations should
subsequently share findings from investigations with these bodies where issues of
potential national learning for wider sharing are identified.
Learning from Serious Case Reviews (SCR)
Executive representatives from the NHS are part of the local Safeguarding Adults
Board (SAB) arrangements in each area and they are responsible for ensuring that
communication between the SAB and the NHS Board is maintained. Learning
lessons is the prime rationale of SCRs, and SABs are responsible for commissioning
each SCR; sharing the learning across all organisations; and monitoring at agreed
review periods whether the lessons have been taken on board. The SAB is
responsible for ensuring that they receive regular progress reports on a
commissioned SCR and to take action if the delay appears unreasonable. NHS
organisations in partnership with the SAB should have local policies for
implementing the findings from SCR, a process to report to their own boards, and
action plans to implement and monitor changes in practice.
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10
Equality Impact Assessment
The organisation should identify who will undertake the Equality Impact Assessment which is
required to consider the needs and assess the impact of this document in accordance with
the Organisation-wide Document for the Development and Management of Procedural
Documents. The Equality Impact Assessment Tool found at Appendix E of the Organisationwide Document for the Development and Management of Procedural Documents could be
completed and form part of the body of the document, but as a minimum a statement
should be included within the document to demonstrate that an Equality Impact Assessment
has been carried out and that the document does not discriminate, highlighting any areas of
good practice or risk areas requiring attention.
e
11
Monitoring Compliance with the Document
11.1
Process for Monitoring Compliance
This section should identify how the organisation plans to monitor compliance with
the Organisation-wide Document for the Reporting and Management of Incidents
Including Serious Incidents. As a minimum it should include the review/monitoring
of all the minimum requirements within the NHSLA Risk Management Standards.
The following list is a guide to issues which could be considered within this section
and should be added to where appropriate:
11.2

Who will perform the monitoring?

When will the monitoring be performed?

How are you going to monitor?

What will happen if any shortfalls are identified?

Where will the results of the monitoring be reported?

How will the resulting action plan be progressed and monitored?

How will learning take place?
Standards/Key Performance Indicators
This section could contain auditable standards and/or key performance indicators
(KPIs) which may assist the organisation in the process for monitoring compliance.
12
References
This section should contain the details of any reference materials reviewed in the
development of the procedural document.
Listed below are some useful sources of reference material:
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12.1
Legislation

Health and Safety (Consultation with Employees) Regulations 1996 SI 1996/1513

Public Interest Disclosure Act 1998
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12.2
Guidance from Other Organisations

Department of Health website offers further information and resources at
www.dh.gov.uk

Health Service Circular 1999/198 The Public Interest Disclosure Act 1998:
Whistle blowing in the NHS (1999)

Memorandum of understanding: Investigating patient safety incidents
involving unexpected death or serious untoward harm: A protocol for liaison
and effective communications between the National Health Service,
Association of Chief Police Officers and Health and Safety Executive (2004)

Independent investigation of adverse events in mental health services (2005)

Safety First. A report for patients, clinicians and healthcare managers (2006)

The NHS Constitution: The NHS belongs to us all (2010)

General Medical Council (GMC) (2008) ‘Raising concerns about patient safety:
Guidance for doctors’ GMC website page

Health and Safety Executive website provides further information and resources at
www.hse.gov.uk

‘What is RIDDOR?’ HSE website

Work Related Death P16 Protocol and Guidance (2003)

Consulting employees on health and safety: A brief guide to the law (2008)

Involving your workforce in health and safety: Good practice for all
workplaces (2008)

House of Commons. (2009) House of Commons Health Committee: Patient Safety:
Sixth Report of Session 2008-09, Volume I

National Patient Safety Agency (NPSA) website offers further information and
resources on incident reporting at http://www.npsa.nhs.uk/

‘Incident decision tree’ Online tool

Seven Steps to Patient Safety in Primary Care Trusts (2006)

Briefing Issue 161: Act on reporting (2008)

National Framework for Reporting and Learning from Serious Incidents
Requiring Investigation (2009)

National Reporting and Learning Service (NRLS) Data Quality Standards:
Guidance for Organisations Reporting to the Reporting and Learning System
(RLS) (2009)

Patient Safety Alert: Update WHO Surgical Safety Checklist (2009)
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13

Questions are the answer! Seven questions every board member should ask
about patient safety (2009)

Medical Error: What to do if things go wrong: A guide for junior doctors
(2010)

Never Events: Framework – Update for 2010/11: Process and action for
Primary Care Trusts (2010)

National Screening Committee, NHS Cancer Screening Programmes (2010)
Managing Serious Incidents in National Screening Programmes

NHS Security Management Service (2010) Security Incident Reporting System

Patient Safety First (2009) The ‘How to Guide’ for Implementing Human Factors in
Healthcare
Associated Documentation
This section should provide a cross reference to any other related organisational procedural
document(s).
The following list is a guide only and is not exhaustive:
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
Complaints management

Claims management

Learning

Being open

Risk management

Investigation and root cause analysis

Supporting staff
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Appendix A - Incident Reporting Timescales
Appendix B - Incident Reporting Form
Appendix C - Guide to Incident Form Completion
Appendix D - Risk Grading Tool - 5x5
Organisation to develop
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Appendix E - Serious Incident Grading Tool
Grade 0
Action required:
Notification only - it is unclear if a serious incident has occurred.
The provider organisation must update the commissioning body/SHA with further information within
three working days of a grade 0 incident being notified.
If within three working days it is found not to be a serious incident, it can be downgraded with the
agreement of the accountable SHA/commissioning body.
If a serious incident has occurred it will be regraded as a grade 1 or 2.
Grade 1
Action required:
Monitoring required:
Examples:
Commissioning bodies will
Local monitoring
Examples of cases: ‐
monitor the case and report
 The commissioning body
 Mental Health - deaths in
findings, recommendations
and/or SHA will close the
the community
and associated action plans to
incident when it is satisfied the  HCAI outbreaks
the SHA.
investigation,
 Unavoidable/unexplained
recommendations and action
death
SHA will monitor progress on
plan are satisfactory, and local  Mental health a quarterly basis with the
monitoring arrangements are
attempted suicides as
commissioning body unless
in place and working
inpatients
earlier discussion is required
efficiently.
 Ambulance services
or the serious incident is re-  Publish incident details within
missing target for arrival
graded.
Annual Reports.
resulting in death/severe
harm to patient
Comprehensive Investigation Timescales:‐
 Data loss and information
Root Cause Analysis (RCA) Up to 45 working days/9
security (DH Criteria level
required Level 2 Investigation weeks from the date the incident
2)
is notified to the commissioning
 Grade 3 pressure ulcer
body/SHA.
develops
 Poor discharge planning
causes harm to patient
Grade 2
Action required:
Monitoring required:
Example of cases:
Case will be monitored by the SHA/commissioning body
 Maternal deaths
SHA/commissioning body/LA
 Incidents involving an
 Inpatient suicides
in conjunction with the
independent investigation or
(including following
provider organisation.
inquiry or those considered
absconsion)*
high risk will continue to be
 Data loss and information
The SHA will review findings,
monitored by the
security (DH Criteria level
recommendations and
SHA/commissioning body or LA
3-5)
associated action plans.
until evidence is provided that
 Never Events
each action point has been
 Accusation of
For ‘Never Events’, the
implemented. Incidents
physical/sexual
commissioning body will be
involving adult or child abuse
misconduct or harm is
obliged to monitor overall
are referred to local
made
numbers and report these in
safeguarding arrangements.
 Homicides following
its annual reporting
 Publish quarterly reports.
recent contact with
arrangements.
mental health services*
Timescales:
Comprehensive Investigation For Independent Investigations
* Mental Health incidents
(RCA Level 2 investigation)
allow up to 26 weeks/6 months for should refer to DH guidance:
(as above) or Independent
completion of the investigation.
Independent investigation of
Investigation (RCA Level 3
Extensions can be granted on an
adverse events in mental
Investigation)
individual case by case basis by the health services (2005).
SHA/commissioning body.
*Working day ‐ Days that exclude weekends and bank holidays (Run from 23:59 on the day the incident is
raised to 23:59 on the day the incident is reported)
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Appendix F - Grading and Timescales for Investigation
Incident
grading
Investigation type
Timescales for completion of
investigation
Grade 1
Comprehensive Investigation (RCA Level 2 Investigation)
 Conducted to a high level of detail, including all
elements of a thorough and credible investigation.
 Conducted by a multidisciplinary team, or involves
experts/expert opinion/independent advice or
specialist investigator(s).
 Conducted by staff not involved in the incident,
locality or directorate in which it occurred.
 Overseen by a director level chair or facilitator.
 Led by person(s) experienced and/or trained in RCA,
human error and effective solutions development.
 Includes patient/relative/carer involvement and
should include an offer to patient/relative/carer of
links to independent representation or advocacy
services.
 May require management of the media via the
organisation’s communications department.
 Includes robust recommendations for shared learning,
locally and/or nationally as appropriate.
 Results in full report with an executive summary and
appendices.
Comprehensive Investigation (RCA Level 2
Investigation)
(As above) or Independent Investigation (RCA Level 3
Investigation)
 Must be commissioned and coordinated by the
Commissioning body or SHA and independent to the
provider organisation service(s) and organisation(s)
involved in the incident, for independent
investigations only.
 Commonly considered for incidents of high public
interest or attracting media attention.
 An independent investigation must be conducted for
mental health homicides (where there has been
recent contact with mental health services) that meet
Department of Health Guidance.
 Should be conducted where Article 2 of the European
Convention on Human Rights is, or is likely to be,
engaged.
Up to 45 working days/9
weeks from the date the
incident is notified to the
commissioning body/SHA.
Grade 2
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Comprehensive investigations
can be completed more quickly if the
provider organisation wishes and
extensions beyond the 45
days can be agreed between
the provider organisation and
commissioning body/SHA.
Up to 60 working days/12
weeks from the date the incident is
notified to the commissioning
body/SHA.
Comprehensive investigations can be
completed more quickly if the provider
organisation wishes and extensions
beyond the 60
days can be agreed between
the provider organisation and
commissioning body/SHA.
For independent investigations allow
up to 26 weeks/6 months for
completion of the investigation.
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Appendix G - List External Stakeholders
The document must detail which other external bodies need to be informed of/involved in the
actual investigation of the incident.
The following list is a guide only and is not exhaustive:

Department of Health Patient Safety Policy Branch

Department of Health NHS Contracting

Welsh Assembly Government

Other NHS organisations

Strategic Health Authorities

Care Quality Commission

Monitor

National Patient Safety Agency (NPSA)

NHS Litigation Authority (NHSLA)

Medicines and Healthcare Products Regulatory Agency (MHRA)

Health and Safety Executive (HSE)

Area Child Protection Committee

Health Protection Agency

NHS Confederation

NHS Business Services Authority

NHS Protect

Connecting for Health

National Blood Service

Audit Commission

Confidential Enquiries & Inquiries

NPSA National Clinical Assessment Service

Independent Healthcare Advisory Service

NHS Information Centre for Health and Social Care

NPSA National Research Ethics Service

National Screening Programmes

SHOT (Serious Hazards of Transfusion)

The police

HM Coroner

Social services

CORESS (Confidential Reporting System for Surgery)
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
Legal advisors

Medical defence organisations
Incidents Occurring Across the Boundaries of Two or More Commissioning Bodies
Where a serious incident crosses the boundary of two or more commissioning bodies, the
commissioning bodies concerned will liaise to ensure each other is notified, a lead commissioning
body is identified and a timescale is locally agreed.
Incidents Involving More than one Provider Organisation
If more than one organisation is involved in a serious incident, the organisation which identified the
incident can make the initial notification having first made contact, wherever possible, with the
organisation where it originated.
The lead organisation must be identified and agreed (with clear responsibilities) at this point with
the other organisations involved. The named lead/point of contact should be clearly identified to
the SHA/commissioning body.
NHS organisations have a primary responsibility to investigate and take preventative action when
things go wrong in order to ensure the safety and well-being of patients and staff so all stakeholders
have an obligation to collaborate. The only exception to this may be when dealing with a
‘safeguarding’ alert.
Incidents Involving the Health & Safety Executive (HSE) and the Police
The Memorandum of understanding: Investigating patient safety incidents involving unexpected
death or serious untoward harm: A protocol for liaison and effective communications between the
National Health Service, Association of Chief Police Officers and Health and Safety Executive
published by the Department of Health in February 2006 provides a protocol for liaison and effective
communication between the NHS, the Health & Safety Executive (HSE) and the Association of Chief
Police Officers with regard to investigating patient safety incidents (unexpected death or serious
untoward harm).
Reporting of Serious Incidents to the Care Quality Commission
Providers are required to notify the Care Quality Commission (CQC) either directly or via other
bodies, of certain categories of incidents. The types of incident and reporting arrangements are
defined in The Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations
2009 SI 2009/660 and accompanying guidance about compliance.
Independent Healthcare Provider Organisations and Practitioners
A serious incident involving a patient in receipt of NHS funded care provided by an independent
sector provider organisation must be notified by the NHS provider organisation to the relevant
bodies as follows:
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National Contracts
In the case of an independent sector provider organisation responsible for providing health care
services under national contract, all serious incidents should be reported directly to:

the lead commissioning/sponsoring body;

NHS Contracting at the Department of Health;

where appropriate, to comply with local safeguarding arrangements;

Care Quality Commission (CQC).
The commissioning body will report the incident to the SHA and the NPSA.
Only serious incidents should be reported in accordance with the above requirements. However,
independent providers of health care may also be required to report other types of incident to their
lead commissioning body as part of their NHS contract or to other bodies as required in national
legislation.
Local Contracts
In the case of an independent sector provider organisation responsible for providing health care
services under local contract, all serious incidents are reported directly to the lead
commissioning/sponsoring body (and where appropriate, to local safeguarding arrangements). The
commissioning body will report the incident to the SHA through an agreed, secure protocol.
If the independent sector provider organisation is registered with the CQC all serious incidents
involving patients are also required to be reported by the provider organisation to the CQC.
Where a serious incident from an independent sector provider organisation is discovered in the first
instance by an NHS organisation, it should be immediately reported to the independent sector
service provider organisation concerned. The only exception to this would be where the incident is
or may be abuse, in which case local safeguarding procedures should be followed. The independent
sector provider organisation is then required to report the adverse incident in line with their
contractual obligations.
The NHS organisation concerned should also inform the lead
commissioning/sponsoring body about the incident. Subsequently, agreement should be reached
between the parties about who leads the investigation.
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Appendix H - Action Learning Points
Responsibilities for
sharing learning
With whom
Example of communication
Local and Organisation
Learning
Provider organisation(s)
where the incident
occurred
Local:
 Patient and their family/carers
directly involved in the incident
where appropriate
 Staff directly involved in the
incident
 Similar services/specialities to the
service involved in the incident

Organisational:
 Other departments/divisions for
lessons with wider organisational
applicability
 Across the organisation by
improvements in process/policy
and systems
NPSA and other bodies
with a remit for safety
and serious incidents
(MHRA, HPA, CfH,
CFSMS, CQC etc)
Professional networks,
bodies and associations
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As appropriate:
 All relevant health care sectors and
organisations
 Professional networks, bodies and
associations
 Manufacturers and commercial
enterprises
 International safety and quality
networks and partners as
appropriate
 Other bodies with a remit for safety
and serious incidents
 Members
 Other networks and associations
March 2012






















Meetings with patients and
their families
Presentations at staff meetings
Team meetings
E‐bulletins and Newsletters
Intranet site
Public web site
Public Board Papers
Notice boards
Email
Internal alert systems
Risk and Governance
Committee Meeting minutes
Risk management, incident
reporting and investigation
training courses (e.g. use of
case studies)
Central Alerting System
(CAS), Chief Executive Bulletin,
CMO Bulletin, etc
Conferences, seminars and
workshops
Alerts, guidance, information,
newsletters
E‐networks
Local organisation liaison/link
officers
Professional networks, bodies
and associations
E‐networks
Letters to members
Newsletters and bulletins
Educational meetings
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Appendix I - Guidance on How to Write a Statement
Organisation to develop
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Appendix J - Investigation Report:
NPSA Concise Investigation Report Template (2010). A Comprehensive and Independent
Investigation Report Template is also available on the NPSA website: www.npsa.nhs.uk
Root Cause Analysis Investigation Report
Incident description and consequences
Incident description:
Incident date:
Incident type:
Specialty:
Actual effect on patient:
Actual severity of the incident:
Level of investigation
Level 1 – Concise investigation
Involvement and support of patient and relatives
Add text here
FINDINGS:
Detection of incident
Add text here
Care and service delivery problems
Add text here
Contributory factors
Add text here
Root causes
Add text here
Lessons learned
Add text here
CONCLUSIONS:
Recommendations
Add text here
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Arrangements for Shared Learning
Add text here
Author and Job Title
Add text here
Report Date
Chronology (timeline) of events
Date & Time
Event
See also ‘Types of Preventative Actions Planned’ tool at www.npsa.nhs.uk/rca
Action Plan
Action 1
Action 2
Action 3
Root CAUSE
EFFECT on Patient
Recommendation
Action to Address Root
Cause
Level for Action
(Org, Direct, Team)
Implementation by:
Target Date for
Implementation
Additional Resources
Required
(Time, money, other)
Evidence of Progress and
Completion
Monitoring & Evaluation
Arrangements
Sign off - action
completed date:
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
See also ‘Types of Preventative Actions Planned’ tool at www.npsa.nhs.uk/rca
Action Plan
Action 1
Action 2
Action 3
Sign off by:
V.5
March 2012
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
Appendix K - Template Document for the Reporting and Management of Incidents
Including Serious Incidents
NHS Trust
An Organisation-wide Document for the
Reporting and Management of Incidents
Including Serious Incidents
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Name of executive lead:
Date issued:
Review date:
Target audience:
V.5
March 2012
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
Contents
1
Introduction ........................................................................................................... 36
2
Purpose .................................................................................................................. 36
3
Explanation of Terms ............................................................................................. 36
4
Duties ..................................................................................................................... 36
4.1
4.2
Duties within the Organisation ............................................................................................. 36
Committees and Groups with Overarching Responsibilities ................................................ 36
Response, Communication and Notification ......................................................... 36
5
5.1
5.2
5.3
5.4
5.5
Immediate Response by the Organisation ............................................................................ 36
Reporting the Incident .......................................................................................................... 36
Patient/Relative/Visitor/Contractor Communication and Support ...................................... 36
Internal Communication ....................................................................................................... 36
External Stakeholder Notification ......................................................................................... 36
Communication with Staff ..................................................................................... 36
6
6.1
6.2
Communication Following an Incident ................................................................................. 36
Process by which to Raise Concerns ..................................................................................... 37
Media Involvement ................................................................................................ 37
7
7.1
7.2
7.3
Media Unaware of Serious Incident ..................................................................................... 37
Media Unaware but Proactive Media Handling Necessary .................................................. 37
Media Aware of Serious Incident .......................................................................................... 37
8
Hotline Arrangements ........................................................................................... 37
9
Incident Investigation ............................................................................................ 37
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
Incident Grading and Appropriate Levels of Investigations .................................................. 37
Responsibility for Investigation............................................................................................. 37
Responsibility for Causal Factor Analysis .............................................................................. 37
Responsibility for Causal Factor Analysis Post Investigation ................................................ 37
Involving Patients and their Families in Investigations into Serious Incidents ..................... 37
Involvement of Relevant Stakeholders ................................................................................. 37
Root Cause Analysis (RCA) and Investigation Report............................................................ 37
Recommendations and Action Planning ............................................................................... 37
Monitoring of Action Plans ................................................................................................... 38
Process of Ensuring Continual Risk Reduction Following the Implementation of Action Plans
38
Sharing of Lessons Learnt ..................................................................................................... 38
10
Equality Impact Assessment ............................................................................... 38
11
Monitoring Compliance with the Document ..................................................... 38
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
11.1
11.2
12
12.1
12.2
13
Process for Monitoring Compliance ..................................................................................... 38
Standards/Key Performance Indicators ................................................................................ 38
References .......................................................................................................... 38
Legislation ............................................................................................................................. 38
Guidance from Other Organisations ..................................................................................... 38
Associated Documents ....................................................................................... 38
Appendix A
Incident Reporting Timescales.............................................................. 38
Appendix B
Incident Reporting Form (organisation’s own) ..................................... 38
Appendix C
Guide to Incident Form Completion ..................................................... 38
Appendix D
Risk Grading Tool - 5x5 (organisation’s own) ....................................... 38
Appendix E
Serious Incident Grading Tool (organisation’s own) ............................ 38
Appendix F
Grading and Timescales for Investigation (organisation’s own) .......... 38
Appendix G
List of External Stakeholders ................................................................ 38
Appendix H
Action Learning Points .......................................................................... 39
Appendix I
Guidance on How to Write a Statement .............................................. 39
Appendix J
Investigation Report: Concise Investigation Report Template............. 39
Appendix K
Checklist for the Review and Approval of Procedural Documents ...... 39
Appendix L
Version Control Sheet ........................................................................... 39
Appendix M
Plan for Dissemination .......................................................................... 39
Appendix O
Equality Impact Assessment Tool ......................................................... 39
Examples of the Checklist for the Review and Approval of Procedural Documents, Version Control
Sheet, Plan for Dissemination and the Equality Impact Assessment Tool can all be found within the
Organisation-wide Document for the Development and Management of Procedural Documents on
the NHSLA website.
Appendix B in the Organisation-wide Document for the Development and Management of Procedural
Documents contains a flowchart to assist with the process for the creation and implementation of
procedural documents.
Review and Amendment Log
Version no.
V.5
Type of change
Date
March 2012
Description of change
Page 35 of 39
An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
1
Introduction
2
Purpose
3
Explanation of Terms
4
Duties
5
6
4.1
Duties within the Organisation
4.2
Committees and Groups with Overarching Responsibilities
Response, Communication and Notification
5.1
Immediate Response by the Organisation
5.2
Reporting the Incident
5.3
Patient/Relative/Visitor/Contractor Communication and Support
5.4
Internal Communication
5.5
External Stakeholder Notification
Communication with Staff
6.1
V.5
Communication Following an Incident
March 2012
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
6.2
7
Process by which to Raise Concerns
Media Involvement
7.1
Media Unaware of Serious Incident
7.2
Media Unaware but Proactive Media Handling Necessary
7.3
Media Aware of Serious Incident
8
Hotline Arrangements
9
Incident Investigation
V.5
9.1
Incident Grading and Appropriate Levels of Investigations
9.2
Responsibility for Investigation
9.3
Responsibility for Causal Factor Analysis
9.4
Responsibility for Causal Factor Analysis Post Investigation
9.5
Involving Patients and their Families in Investigations into Serious Incidents
9.6
Involvement of Relevant Stakeholders
9.7
Root Cause Analysis (RCA) and Investigation Report
9.8
Recommendations and Action Planning
March 2012
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
9.9
Monitoring of Action Plans
9.10
Process of Ensuring Continual Risk Reduction Following the Implementation of
Action Plans
9.11
Sharing of Lessons Learnt
10
Equality Impact Assessment
11
Monitoring Compliance with the Document
12
13
V.5
11.1
Process for Monitoring Compliance
11.2
Standards/Key Performance Indicators
References
12.1
Legislation
12.2
Guidance from Other Organisations
Associated Documents
Appendix A
Incident Reporting Timescales
Appendix B
Incident Reporting Form (organisation’s own)
Appendix C
Guide to Incident Form Completion
Appendix D
Risk Grading Tool - 5x5 (organisation’s own)
Appendix E
Serious Incident Grading Tool (organisation’s own)
Appendix F
Grading and Timescales for Investigation (organisation’s own)
Appendix G
List of External Stakeholders
March 2012
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An Organisation-wide Document for the Reporting and Management of Incidents Including Serious Incidents
V.5
Appendix H
Action Learning Points
Appendix I
Guidance on How to Write a Statement
Appendix J
Investigation Report: Concise Investigation Report Template
Appendix K
Checklist for the Review and Approval of Procedural Documents
Appendix L
Version Control Sheet
Appendix M
Plan for Dissemination
Appendix O
Equality Impact Assessment Tool
March 2012
Page 39 of 39